Evaluation of Tofacitinib in Early Diffuse Cutaneous Systemic Sclerosis (dcSSc)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT03274076
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    Oral medication tofacitinib 5 mg twice a day for 24 weeks.
  • Placebo Oral Tablet — DRUG
    Oral Placebo 5 mg twice a day for 24 weeks

Study Details

This Phase I/II placebo controlled trial will evaluate tofacitinib in subjects with diffuse cutaneous systemic scleroderma (dcSSc). This trial is intended to provide safety, and tolerability data in participants with dcSSc when dosed to target exposures similar to that used in adult participants with rheumatoid arthritis.

Key Dates

Start date
Sep 25, 2017
Status verified
Apr 2020
Primary completion
Apr 8, 2019
Completion
Nov 15, 2019

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tofacitinib
    5mg Tofacitinib twice a day
  • Placebo Comparator: Placebo
    5mg Placebo twice a day

Primary Outcome Measure

Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24 [ Time Frame: 24 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48104-
University of PittsburghPittsburghPennsylvania15261-

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University of Michigan· Ann Arbor, MIUniversity of Pittsburgh· Pittsburgh, PA

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